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510(k) K143177

Device
KleenGel Dispenser
Applicant
KleenGel, LLC
510(k) number
K143177
Product code
KYX  
Decision
Substantially Equivalent (SESE)
Decision date
2015-09-14
Date received
2014-11-04
Regulation
880.6430
Classification name
Dispenser, Liquid Medication
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Suzanne Mair
Address
136 NW 16th St. Boca Raton FL US 33432 33432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KYX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980109CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSERSangstat Medical Corp.1998-08-18
K954181CANYONS BI-DIRECTIONAL CHECK VALVECanyon Medical Products1995-11-29
K830571BOTTLE ADAPTERBurron Medical Products, Inc.1983-03-24
K801008MULTI-AD FLUID DISPENSING PUMP MP-3000Burron Medical Products, Inc.1980-06-02
K800362FLUID DISPENSING SYSTEMPharmaseal Laboratories1980-03-12
K800437SYRINGE TIP CONNECTORBurron Medical Products, Inc.1980-03-12
K792227MULTI-AD FLUID DISPENSING SYSTEMNational Patent Development Corp.1979-12-20
K781364PINT BOTTLE WELLBaxa Corp., Sub. of Cook Group, Inc.1978-10-17
K771539STEPPERTridak1977-10-07
K760517CUP, DISPOSABLE MEDICINELandmark Plastics1976-11-12

Legacy Summary#

summary

FDA Review#

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